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The DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500, APLIO 400 MODEL TUS-A400 and APLIO 300 MODEL TUS-A300 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculoskeletal (both conventional and superficial).

The DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500. APLIO 400 MODEL TUS-A400 and APLIO 300 MODEL TUS-A300 are mobile system. These systems are Track 3 devices that employ a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.

The provided text is a 510(k) summary for the Toshiba DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500, APLIO 400 MODEL TUS-A400, and APLIO 300 MODEL TUS-A300 Version 2.1. It primarily focuses on demonstrating substantial equivalence to a predicate device (Toshiba DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500 / APLIO 400 MODEL TUS-A400 / APLIO 300 MODEL TUS-A300 V2.0; 510(k) control number K110870) and outlining the intended uses for various transducers.

Based on the provided document, the information requested in your prompt about acceptance criteria and a study proving performance (specifically in the context of AI/ML or new clinical parameters) is not present. This document predates the widespread regulatory submissions for AI/ML devices in medical imaging, and its focus is on general ultrasound system functionality and traditional clinical applications.

Therefore, I cannot provide a table of acceptance criteria and reported device performance for AI features, nor can I provide details about sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC comparative effectiveness studies, or standalone algorithm performance studies related to AI.

The document does include detailed tables for each transducer showing the "Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:", listing various clinical applications and modes of operation. For each application, it indicates whether it's a "P" (previously cleared by FDA) or "E" (added under this appendix) indication, or "N" (new indication) for a very few. This is essentially a declaration of the intended uses, but it does not specify performance acceptance criteria or provide study results to demonstrate performance for these applications.

The document mentions compliance with several standards, such as IEC 60601-1 and its parts, IEC 62304, and AIUM-NEMA UD2/UD3 standards. These are general safety and performance standards for medical electrical equipment and ultrasound output measurement/display. They are compliance standards, not specific acceptance criteria for AI or diagnostic performance in patient studies.

In summary, the provided content is a regulatory submission for device clearance based on substantial equivalence to a predicate device, focusing on intended uses and compliance with general safety and performance standards. It does not contain the kind of detailed information about acceptance criteria and performance studies you're asking for, particularly concerning AI or specific diagnostic efficacy metrics.

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The intended use of this system is to visualize structures, characteristics, and dynamic processes within the human body using ultrasound and to provide image information for diagnosis for cardiac and vascular.

The DIAGNOSTIC ULTRASOUND SYSTEM APLIO ARTIDA (Model SSH-880CV) is intended to be used for the following types of studies: cardiac, transesophageal, abdominal and peripheral vascular.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Peripheral vessel, Abdominal, Small Organ (Specify) (1), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial).

The APLIO ARTIDA SSH-880CV is a mobile Ultrasound Diagnostic System for cardiology and vascular imaging. It has a capability of providing a 3D real time image of a heart as well as 2D images. The system is consists of a main console, a color LCD display and several transducers. The compatible transducers are linear array, curved linear and phased array with a frequency range of 2.5 MHz to 7.5MHz. Accordingly it has various software options for cardiac and vascular examinations.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on the substantial equivalence of the APLIO ARTIDA MODEL SSH-880CV V3.0 (subject device) to the APLIO ARTIDA MODEL SSH-880CV V2.0 (predicate device), with the addition of a new feature: Activation Imaging (AI) - 3D Wall Motion Tracking (3D WMT). The acceptance criteria for this new feature is qualitative and tied to its ability to display activation timing.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 10 subjects.
• Data Provenance: The text states, "A clinical evaluation of Activation Imaging (AI) was conducted at a evaluation site for the validation of AI." No specific country of origin is mentioned, but the submitter's address is in Tustin, CA, USA, and the device manufacturer is Toshiba Medical Systems Corporation, Japan. This suggests it could be a US-based study or an international study. The study was prospective in nature, as indicated by "scheduled for routine Echocardiographic Evaluation."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It only mentions that subjects were "scheduled for routine Echocardiographic Evaluation by their physician," implying that physicians (likely cardiologists or specialized sonographers) were involved in the standard diagnostic process which would inform the assessment of "dyssynchrony."

4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned. The study was a clinical evaluation of the AI feature itself, not a comparison of human readers with vs. without AI assistance. The focus was on whether the AI images provided activation timing, not on how it improved human reader performance.

6. If a Standalone (Algorithm-Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone evaluation was performed. The "pass/fail criterion was used to determine if the AI images provided the activation timing." This directly assesses the algorithm's output without requiring human interpretation for its performance evaluation against a specific criterion.

7. The Type of Ground Truth Used

The ground truth was established by assessing if the AI images "provided the activation timing" for subjects with "dyssynchrony." This implies a clinical assessment of myocardial movement from the acquired 3D images, likely evaluated against established medical understanding of cardiac dyssynchrony and activation timing. While not explicitly stated as "expert consensus," the nature of the evaluation for a diagnostic ultrasound feature inherently relies on clinical judgment and established diagnostic criteria within the medical field. It's an implicit clinical ground truth based on the physician's evaluation rather than a pathology result or outcome data.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. The focus is solely on the clinical evaluation of the new feature.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned, there is no information on how its ground truth was established.

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